Cleared Traditional

K123400 - AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE

K123400 is an FDA 510(k) clearance for AEROBIKA POSITIVE EXPIRATORY PRESSURE D..., manufactured by Trudell Medical Intl.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K123400 · Trudell Medical Intl. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
192d
Days
Class 2
Risk

K123400 is an FDA 510(k) clearance for the AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Trudell Medical Intl. (London, CA). The FDA issued a Cleared decision on May 16, 2013 after a review of 192 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5690 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K123400

510(k) Number K123400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2012
Decision Date May 16, 2013
Days to Decision 192 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 140d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BWF Device Classification - Class 2, Special Controls

Product Code BWF Spirometer, Therapeutic (incentive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BWF Spirometer, Therapeutic (incentive)

All 79
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K123400.
AEROSURE MEDIC
K140772 · Actegy , Ltd. · Dec 2014
VOLUMETRIC INCENTIVE SPIROMETER
K141355 · Besmed Health Business Corporation · Sep 2014
TRIBALL INCENTIVE SPIROMETER
K133873 · Besmed Health Business Corp · Apr 2014
LUNG FLUTE THERAPEUTIC
K091557 · Medical Acoustics · Jan 2010
PARI PEP S
K090829 · Pari Respiratory Equipment, Inc. · Jul 2009
RESPIFIT S, MODEL RS-LR1001004
K080299 · Eumedics Medizintechnik Und Marketing GmbH · Jan 2009